A Physiotherapist Led Intervention to Promote Physical Activity in Rheumatoid Arthritis - a Pilot Study (PIPPRA)

June 10, 2022 updated by: University of Limerick

Rheumatoid arthritis (RA), a chronic, inflammatory condition with increased mortality from cardiovascular disease, is associated with high health care related costs and decreased productivity. Currently, nonpharmacological management guidelines recommend increasing low levels of physical activity in this group to improve health including cardiovascular health, yet research has shown that people who have RA have reduced levels of PA. Interventions targeting PA behaviour in this population have had limited effect to date due to lack of patient involvement in designing the intervention, poor measurement of PA, lack of behaviour change theory underpinning the intervention and have tended to include people who already have some level of PA. Work to underpin a robust intervention to improve PA in this group has been undertaken by members of this study group including validation of an objective measure PA in RA and interviews with people who have RA and rheumatology health professionals to aid in designing an intervention to promote PA.

The aim of this pilot randomised controlled trial (RCT) is to examine the feasibility of a physiotherapist led, behaviour change theory informed, PA intervention to promote PA in people who have RA who have low levels of current PA. This pilot study will determine the rate of recruitment to the study and also determine the acceptability of the intervention to the participants as well as test the feasibility of the secondary disease/PA focused outcome measures.

Participants will be recruited from rheumatology clinics in a large teaching hospital. Participants meeting inclusion criteria will be randomised into an eight week PA intervention (four sessions delivered over an eight week period by a trained physiotherapist) or a control group (PA information leaflet). This pilot randomised study will provide valuable information for the scaling up of a primary care based intervention for this important patient group and in doing so provide an achievable, pragmatic intervention for busy clinicians, who need feasible interventions to appropriately manage complex chronic conditions like RA in a busy primary care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid Arthritis (RA) affects approximately 0.5% of the adult population worldwide. In Ireland c46,000 people have RA, with c2,000 new cases diagnosed annually. Cardiovascular disease (CVD) , infections and lymphoma occur more frequently in this population with increased mortality rates present1. Physical activity (PA) is very important in the management of RA and is an essential in reducing the risk of CVD, improving disease symptoms and quality of life. However, people who have RA tend to have low PA levels, thus improving PA levels is important. Previous interventions which have targeted PA in people who have RA have had limited success in increasing and maintaining PA behaviour change (BC) in the longer term. Reasons for this limited success include short intervention time, inadequate involvement of participants in designing the study, lack of objective measurement of PA and lack of a BC theoretical underpinning. Thus, better intervention design through the incorporation of appropriate BC theory is necessary. Adopting the Behaviour Change Wheel (BCW), facilitates the identification of factors which should be targeted in a BC intervention to promote PA. In order to design a robust intervention to address the issues above, the applicants undertook extensive systematic literature reviewing, objective PA measurement validation and qualitative interviews with people with RA and with rheumatology health professionals, guided by the Medical Research council framework for complex interventions. A pilot intervention is now proposed building on that work to determine the feasibility of a physiotherapist led BC intervention to promote PA in people with RA who have low levels of PA.

The aim of this pilot study is to determine the feasibility and acceptability of a physiotherapist led BC intervention to promote PA in people with RA who are insufficiently physically active compared to a control group who receive a leaflet on PA.

Ethical Approval: approval will be sought in advance of the study start date from Health Service Executive Research ethics committee University Hospitals Limerick.

Trial design: single-centre randomised pilot study, incorporating qualitative interviews to examine acceptability, comparing the intervention with a control.

Methods: Participants, interventions, and outcomes Study setting - Academic teaching hospitals group in Mid-West of Ireland

Interventions The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about PA with a physiotherapist with training in behaviour change techniques and motivational interviewing. Using a range of behaviour change and self-regulation techniques (eg goal-setting, self-monitoring), participants will be guided towards PA maintenance at the end of the 8 weeks. In addition, participants will be signposted to PA classes, facilities and resources in the local community.

The control group (Group B) will receive the same information booklet about PA only. Both groups will continue with their routine care for their condition throughout the study period.

Primary outcome measures will be:

  1. Recruitment rate - the rate of participants recruited to the study versus total potential participants
  2. Retention rate - the number of participants who complete baseline measures and at week 8

Sample Size A target of 40 participants, with 20 participants in both the control and intervention groups. This sample size is expected to provide sufficient data to meet the primary outcomes. A definitive sample size of a large-scale RCT will be determined from the results of this trial.

Data analysis Descriptive statistics will be used to determine the recruitment and retentions rates and to measure change in outcome measures from baseline to T1 and T2. Thematic analysis will be used to analyse the transcribed interviews

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland
        • University of Limerick/University Hospitals Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Rheumatoid arthritis
  • Age over 18 years
  • Classified using Godin-Shephard Leisure-Time Physical Activity Questionnaire as insufficiently active

Exclusion Criteria:

  • Aged less than 18 years
  • People who require a mobility aid to mobilise in their activities of daily living (ADLs)
  • Pregnancy
  • Meeting aerobic physical activity recommendations already

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Physical activity and behaviour change The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about physical activity with a physiotherapist who has training in behaviour change techniques and motivational interviewing. Using a range of behaviour change and self-regulation techniques (eg goal-setting, self-monitoring), participants will be guided towards physical activity maintenance at the end of the 8 weeks. In addition, participants will be signposted to physical activity classes, facilities and resources in the local community. This group will continue with their routine care for their condition throughout the study period.
Behavioral: Physical activity and behaviour change
The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about physical activity to include an initial 1:1 session with a physiotherapist with training in behaviour change techniques and motivational interviewing. Using a range of behaviour change and self-regulation techniques (eg goal-setting, self-monitoring), participants will be guided towards physical activity maintenance at the end of the 8 weeks. In addition, participants will be signposted to physical activity classes, facilities and resources in the local community. This group will continue with their routine care for their condition throughout the study period.
No Intervention: Control Group
The control group (Group B) will receive the same information booklet about physical activity only. This group will continue with their routine care for their condition throughout the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline
The rate of participants recruited to the study versus total potential participants
Baseline
Retention rate
Time Frame: At week 12
The number of participants who complete baseline measures at week 12
At week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity - objective
Time Frame: Baseline, 8 and 24-week follow-up
Physical activity profile measured using accelerometry (ActivPal)
Baseline, 8 and 24-week follow-up
Physical activity - self-report
Time Frame: Baseline, 8 and 24-week follow-up
Self report physical activity (Yale Physical Activity Survey)
Baseline, 8 and 24-week follow-up
Behaviour Change
Time Frame: Baseline, 8 and 24-week follow-up
Theory of planned behaviour questionnaire (TPBQ)
Baseline, 8 and 24-week follow-up
Quality of Life in Rheumatoid Arthritis
Time Frame: Baseline, 8 and 24-week follow-up
Quality of Life in Rheumatoid Arthritis (RAQoL) will be used to examine self-reported quality of life in rheumatoid arthritis
Baseline, 8 and 24-week follow-up
Pain over past 7 days
Time Frame: Baseline, 8 and 24-week follow-up
Visual analogue scale (VAS) will measure self-reported pain levels. 100 mm VAS from 0 (no pain) to 100 (most possible pain).
Baseline, 8 and 24-week follow-up
Fatigue
Time Frame: Baseline, 8 and 24-week follow-up
Bristol RA Fatigue Multi-dimensional Questionnaire (BRAF-MDQ)
Baseline, 8 and 24-week follow-up
Function
Time Frame: Baseline, 8 and 24-week follow-up
Health assessment questionnaire (HAQ)
Baseline, 8 and 24-week follow-up
Sleep
Time Frame: Baseline, 8 and 24-week follow-up
Pittsburgh Sleep Quality Index
Baseline, 8 and 24-week follow-up
Disease activity profile
Time Frame: Baseline, 8 and 24-week follow-up
The Disease Activity Score 28 (DAS28) combines single measures into an overall, continuous measure of rheumatoid arthritis (RA) disease activity. The DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale.
Baseline, 8 and 24-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Limerick

Investigators

  • Principal Investigator: Norelee Kennedy, PhD, University of Limerick

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIPPRA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Physical activity and behaviour change

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe